A Study of the Safety and Efficacy of Golimumab (CNTO 148... | NCT00299546

ID	Type	Description	Link
C0524T11	Other Identifier	Centocor

Name	Class
Schering-Plough	INDUSTRY

Label	Type	Description	Intervention Names
Group 1: Placebo	Placebo Comparator	Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); Golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; Golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period will be until the week-24 database lock.	Drug: Placebo Biological: Golimumab 50 mg
Group 2: Golimumab 50 mg	Experimental	Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); Golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period will be until the week-24 database lock.	Biological: Golimumab 50 mg
Group 3: Golimumab 100 mg	Experimental	Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50 mg. Duration of the blinded period will be until the week-24 database lock.	Biological: Golimumab 100 mg

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	SC injections	Group 1: Placebo
Golimumab 50 mg

Measure	Description	Time Frame
American College of Rheumatology (ACR) 20 Response at Week 14.	ACR 20 response is an improvement of >= 20% from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments ( patient's assessment of pain visual analog scale (VAS), patient's global assessment of disease activity VAS scale, Physician's global assessment of disease activity VAS scale, Health Assessment Questionnaire and C-reactive protein)	Week 14

Measure	Description	Time Frame
American College of Rheumatology (ACR) 50 Response at Week 14	Number of patients who achieved an ACR 50 response at Week (Wk) 14. ACR 50 response is an improvement of >= 50% from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments ( patient's assessment of pain visual analog scale (VAS), patient's global assessemnt of disease activity VAS scale, Physician's global assessment of disease activity VAS scale, Health Assessment Questionnaire and C-reactive protein).

Name	Affiliation	Role
Centocor, Inc. Clinical Trial	Centocor, Inc.	Study Director

PubMed Identifier	Type	Citation	Retractions
27889300	Derived	Vieira MC, Zwillich SH, Jansen JP, Smiechowski B, Spurden D, Wallenstein GV. Tofacitinib Versus Biologic Treatments in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors: Results From a Network Meta-analysis. Clin Ther. 2016 Dec;38(12):2628-2641.e5. doi: 10.1016/j.clinthera.2016.11.004. Epub 2016 Nov 24.
27803138

ID	Title	Description
FG000	Group 1: Placebo	Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); Golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; Golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-24 database lock.

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

American College of Rheumatology (ACR) 20 Response at Week 14.

ACR 20 response is an improvement of >= 20% from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments ( patient's assessment of pain visual analog scale (VAS), patient's global assessment of disease activity VAS scale, Physician's global assessment of disease activity VAS scale, Health Assessment Questionnaire and C-reactive protein)

Randomized participants (excluding 1 site). Participants considered non-responders if used any prohibited medications or discontinued subcutaneous study agent due to lack of efficacy. Missing ACR components imputed by Last Observation Carried Forward unless all ACR components were missing; in which case considered non-responders.

Posted

Number

participants

Week 14

ID	Title	Description
OG000	Group 1: Placebo	Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.
OG001	Group 2: Golimumab 50 mg	Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.
OG002	Group 3: Golimumab 100 mg	Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50 mg. Duration of the blinded period was until the week-24 database lock.
OG003	Combined Golimumab	Combines Group 2 (golimumab 50 mg) and Group 3 (golimumab 100 mg).

Units	Counts
Participants	OG000150 OG001147 OG002148 OG003

Title

Denominators

Categories

Title	Measurements
	OG00027 OG00151 OG00254 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG003	Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Group 1 vs. Combined Groups 2 and 3. A sample size of 140 patients per group provides a >90% power assuming 50% of patients used Methotrexate (MTX) at baseline and 30% ACR 20 response in placebo and 40~55% ACR 20 response in golimumab groups.	Cochran-Mantel-Haenszel	Stratified by baseline Methotrexate (MTX)	<0.001	A positive test is concluded if there is a significant difference between combined golimumab and placebo groups and at least one of the pair-wise comparisons at 0.05 level.												No

Secondary

American College of Rheumatology (ACR) 50 Response at Week 14

Number of patients who achieved an ACR 50 response at Week (Wk) 14. ACR 50 response is an improvement of >= 50% from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments ( patient's assessment of pain visual analog scale (VAS), patient's global assessemnt of disease activity VAS scale, Physician's global assessment of disease activity VAS scale, Health Assessment Questionnaire and C-reactive protein).

Posted

Number

participants

Week 14

ID	Title	Description
OG000	Group 1: Placebo	Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.
OG001	Group 2: Golimumab 50 mg	Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.

Secondary

Disease Activity Index Score 28 (DAS 28) (Using C-reactive Protein) Response at Week 14

DAS 28 using C-reactive protein (CRP) is an index to measure disease activity in participants with rheumatoid arthritis which combines tender joint count (28 joints), swollen joint count (28 joints), CRP value, and participant's global assessment of disease activity (using a Visual Analog Scale of 0 to 100 mm). The DAS 28 score ranges from 0 (best) to 10 (worst).

Randomized participants (excluding 1 site). Participants considered non-responders if used any prohibited medications or discontinued subcutaneous study agent due to lack of efficacy. Missing DAS 28 components imputed by Last Observation Carried Forward unless all components were missing; in which case considered non-responders.

Posted

Number

participants

Week 14

ID	Title	Description
OG000	Group 1: Placebo	Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.
OG001	Group 2: Golimumab 50 mg	Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.

Secondary

American College of Rheumatology (ACR) 20 at Week 24

Number of patients who achieved ACR 20 response at Week (Wk) 24. ACR 20 response is an improvement of >= 20% from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments ( patient's assessment of pain visual analog scale (VAS), patient's global assessemnt of disease activity VAS scale, Physician's global assessment of disease activity VAS scale,HAQ and CRP)

Randomized participants (excluding 1 site). Participants considered non-responders if used any prohibited medications or discontinued SC study agent due to lack of efficacy. Missing ACR components imputed by LOCF unless all components were missing; in which case considered non-responders. Wk 16 ACR response used for change in study tx.

Posted

Number

participants

From Baseline to Week 24

ID	Title	Description
OG000	Group 1: Placebo	Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.
OG001	Group 2: Golimumab 50 mg	Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.

Secondary

Health Assessment Questionnaire (HAQ) Score at Week 24

Improvement from baseline in HAQ score at Week 24. This 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area based on the worst score from the questions that pertain to that task. The HAQ score is determined by the average of the 8 scores; HAQ ranges from 0 to 3.

Randomized participants (excluding 1 site). Missing scores imputed by Last Observation Carried Forward. Week 16 scores were used for participants with change in study treatment.

Posted

Median

Inter-Quartile Range

scores on a scale

From Baseline to Week 24

ID	Title	Description
OG000	Group 1: Placebo	Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.
OG001	Group 2: Golimumab 50 mg	Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pancytopenia	Blood and lymphatic system disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0020 affected195 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0020 affected195 at risk
Acute Coronary Syndrome	Cardiac disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0022 affected195 at risk
Acute Myocardial Infarction	Cardiac disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Angina Pectoris	Cardiac disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0021 affected195 at risk
Aortic Valve Incompetence	Cardiac disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0020 affected195 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0022 affected195 at risk
Atrial Flutter	Cardiac disorders	MedDRA Version 15.0	Systematic Assessment	EG0001 affected98 at risk EG0010 affected138 at risk EG0020 affected195 at risk
Cardiac Failure Congestive	Cardiac disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0012 affected138 at risk EG0020 affected195 at risk
Cardiomyopathy	Cardiac disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Cardiovascular Disorder	Cardiac disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Coronary Artery Disease	Cardiac disorders	MedDRA Version 15.0	Systematic Assessment	EG0001 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Myocardial Infarction	Cardiac disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0012 affected138 at risk EG0020 affected195 at risk
Sick Sinus Syndrome	Cardiac disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Supraventricular Tachycardia	Cardiac disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0020 affected195 at risk
Tachycardia	Cardiac disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Torsade De Pointes	Cardiac disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Branchial Cleft Cyst	Congenital, familial and genetic disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Adrenal Insufficiency	Endocrine disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0001 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Colitis	Gastrointestinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0022 affected195 at risk
Colitis Ulcerative	Gastrointestinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0001 affected98 at risk EG0010 affected138 at risk EG0020 affected195 at risk
Colonic Polyp	Gastrointestinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0001 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Diverticulum Intestinal	Gastrointestinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Gastric Polyps	Gastrointestinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Gastritis	Gastrointestinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0022 affected195 at risk
Gastritis Erosive	Gastrointestinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0020 affected195 at risk
Gastrointestinal Disorder	Gastrointestinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Inguinal Hernia	Gastrointestinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Large Intestine Perforation	Gastrointestinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Nausea	Gastrointestinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0001 affected98 at risk EG0010 affected138 at risk EG0020 affected195 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0012 affected138 at risk EG0020 affected195 at risk
Rectal Haemorrhage	Gastrointestinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0001 affected98 at risk EG0010 affected138 at risk EG0020 affected195 at risk
Small Intestinal Obstruction	Gastrointestinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0021 affected195 at risk
Splenic Artery Aneurysm	Gastrointestinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0020 affected195 at risk
Varices Oesophageal	Gastrointestinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0020 affected195 at risk
Vomiting	Gastrointestinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0002 affected98 at risk EG0010 affected138 at risk EG0020 affected195 at risk
Chest Pain	General disorders	MedDRA Version 15.0	Systematic Assessment	EG0001 affected98 at risk EG0010 affected138 at risk EG0020 affected195 at risk
Device Breakage	General disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Device Dislocation	General disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0020 affected195 at risk
Device Failure	General disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Generalised Oedema	General disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Hernia	General disorders	MedDRA Version 15.0	Systematic Assessment	EG0001 affected98 at risk EG0010 affected138 at risk EG0020 affected195 at risk
Multi-Organ Failure	General disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Non-Cardiac Chest Pain	General disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Pain	General disorders	MedDRA Version 15.0	Systematic Assessment	EG0001 affected98 at risk EG0010 affected138 at risk EG0020 affected195 at risk
Pyrexia	General disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0021 affected195 at risk
Bile Duct Stone	Hepatobiliary disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Biliary Cirrhosis Primary	Hepatobiliary disorders	MedDRA Version 15.0	Systematic Assessment	EG0001 affected98 at risk EG0010 affected138 at risk EG0020 affected195 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA Version 15.0	Systematic Assessment	EG0001 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Cholecystitis Acute	Hepatobiliary disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0020 affected195 at risk
Cholecystitis Chronic	Hepatobiliary disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0021 affected195 at risk
Drug-Induced Liver Injury	Hepatobiliary disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Abdominal Abscess	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0021 affected195 at risk
Appendicitis	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0001 affected98 at risk EG0010 affected138 at risk EG0020 affected195 at risk
Bacteraemia	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0020 affected195 at risk
Bronchitis	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0001 affected98 at risk EG0010 affected138 at risk EG0020 affected195 at risk
Cellulitis	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0001 affected98 at risk EG0011 affected138 at risk EG0022 affected195 at risk
Cellulitis Streptococcal	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Diverticulitis	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0012 affected138 at risk EG0022 affected195 at risk
Erysipelas	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Extradural Abscess	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0021 affected195 at risk
Gastroenteritis	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0022 affected195 at risk
Gastroenteritis Salmonella	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0020 affected195 at risk
Herpes Zoster	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0020 affected195 at risk
Histoplasmosis	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Histoplasmosis Disseminated	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0020 affected195 at risk
Infected Skin Ulcer	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0001 affected98 at risk EG0010 affected138 at risk EG0020 affected195 at risk
Infection	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0022 affected195 at risk
Intervertebral Discitis	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0001 affected98 at risk EG0011 affected138 at risk EG0020 affected195 at risk
Lung Infection Pseudomonal	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0020 affected195 at risk
Osteomyelitis	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Pelvic Abscess	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Periorbital Cellulitis	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0001 affected98 at risk EG0011 affected138 at risk EG0020 affected195 at risk
Pneumonia	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0003 affected98 at risk EG0015 affected138 at risk EG00210 affected195 at risk
Post Procedural Infection	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Pulmonary Tuberculosis	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Pyelonephritis	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0020 affected195 at risk
Salpingitis	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0020 affected195 at risk
Sepsis	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0025 affected195 at risk
Staphylococcal Abscess	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0001 affected98 at risk EG0011 affected138 at risk EG0020 affected195 at risk
Staphylococcal Infection	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Subcutaneous Abscess	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0021 affected195 at risk
Tracheobronchitis	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0020 affected195 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0020 affected195 at risk
Urinary Tract Infection	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0012 affected138 at risk EG0025 affected195 at risk
Urosepsis	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0002 affected98 at risk EG0010 affected138 at risk EG0020 affected195 at risk
Ankle Fracture	Injury, poisoning and procedural complications	MedDRA Version 15.0	Systematic Assessment	EG0001 affected98 at risk EG0010 affected138 at risk EG0020 affected195 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Femoral Neck Fracture	Injury, poisoning and procedural complications	MedDRA Version 15.0	Systematic Assessment	EG0001 affected98 at risk EG0011 affected138 at risk EG0021 affected195 at risk
Femur Fracture	Injury, poisoning and procedural complications	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0021 affected195 at risk
Fractured Sacrum	Injury, poisoning and procedural complications	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0021 affected195 at risk
Hip Fracture	Injury, poisoning and procedural complications	MedDRA Version 15.0	Systematic Assessment	EG0001 affected98 at risk EG0011 affected138 at risk EG0021 affected195 at risk
Humerus Fracture	Injury, poisoning and procedural complications	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Lower Limb Fracture	Injury, poisoning and procedural complications	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Meniscus Lesion	Injury, poisoning and procedural complications	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0020 affected195 at risk
Muscle Rupture	Injury, poisoning and procedural complications	MedDRA Version 15.0	Systematic Assessment	EG0001 affected98 at risk EG0010 affected138 at risk EG0020 affected195 at risk
Open Fracture	Injury, poisoning and procedural complications	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0020 affected195 at risk
Pelvic Fracture	Injury, poisoning and procedural complications	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0020 affected195 at risk
Pubis Fracture	Injury, poisoning and procedural complications	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Stress Fracture	Injury, poisoning and procedural complications	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Wound Dehiscence	Injury, poisoning and procedural complications	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0021 affected195 at risk
Diabetic Ketoacidosis	Metabolism and nutrition disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0020 affected195 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0020 affected195 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0001 affected98 at risk EG0012 affected138 at risk EG0021 affected195 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0021 affected195 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0021 affected195 at risk
Bone Disorder	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0020 affected195 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Compartment Syndrome	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0020 affected195 at risk
Intervertebral Disc Protrusion	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0020 affected195 at risk
Joint Effusion	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Joint Swelling	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0020 affected195 at risk
Lumbar Spinal Stenosis	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0020 affected195 at risk
Mobility Decreased	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Neck Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0002 affected98 at risk EG0011 affected138 at risk EG0028 affected195 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0022 affected195 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Pain in Extremity	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Rheumatoid Arthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0004 affected98 at risk EG0012 affected138 at risk EG0028 affected195 at risk
Rheumatoid Nodule	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0020 affected195 at risk
Rotator Cuff Syndrome	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Scleroderma	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0020 affected195 at risk
Spinal Column Stenosis	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0021 affected195 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0020 affected195 at risk
Synovitis	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Tenosynovitis	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0020 affected195 at risk
B-Cell Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0021 affected195 at risk
Basal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0013 affected138 at risk EG0021 affected195 at risk
Breast Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0021 affected195 at risk
Cervix Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 15.0	Systematic Assessment	EG0001 affected98 at risk EG0010 affected138 at risk EG0020 affected195 at risk
Diffuse Large B-Cell Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Lung Carcinoma Cell Type Unspecified Stage Iv	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 15.0	Systematic Assessment	EG0001 affected98 at risk EG0010 affected138 at risk EG0020 affected195 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0020 affected195 at risk
Pancreatic Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 15.0	Systematic Assessment	EG0001 affected98 at risk EG0010 affected138 at risk EG0020 affected195 at risk
Rectal Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Squamous Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0022 affected195 at risk
Squamous Cell Carcinoma of Skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Thyroid Adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Urinary Tract Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Carpal Tunnel Syndrome	Nervous system disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0022 affected195 at risk
Cerebrovascular Accident	Nervous system disorders	MedDRA Version 15.0	Systematic Assessment	EG0001 affected98 at risk EG0013 affected138 at risk EG0021 affected195 at risk
Cervicobrachial Syndrome	Nervous system disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Convulsion	Nervous system disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Demyelination	Nervous system disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0021 affected195 at risk
Hypoaesthesia	Nervous system disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Migraine	Nervous system disorders	MedDRA Version 15.0	Systematic Assessment	EG0001 affected98 at risk EG0010 affected138 at risk EG0020 affected195 at risk
Neuralgia	Nervous system disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Paraesthesia	Nervous system disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Presyncope	Nervous system disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0020 affected195 at risk
Sciatica	Nervous system disorders	MedDRA Version 15.0	Systematic Assessment	EG0001 affected98 at risk EG0010 affected138 at risk EG0020 affected195 at risk
Syncope	Nervous system disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Transient Ischaemic Attack	Nervous system disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Viith Nerve Paralysis	Nervous system disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Depression	Psychiatric disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Mental Status Changes	Psychiatric disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0020 affected195 at risk
Calculus Urinary	Renal and urinary disorders	MedDRA Version 15.0	Systematic Assessment	EG0001 affected98 at risk EG0010 affected138 at risk EG0020 affected195 at risk
Renal Disorder	Renal and urinary disorders	MedDRA Version 15.0	Systematic Assessment	EG0001 affected98 at risk EG0010 affected138 at risk EG0020 affected195 at risk
Renal Failure	Renal and urinary disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Renal Failure Acute	Renal and urinary disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0020 affected195 at risk
Renal Tubular Necrosis	Renal and urinary disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Vesical Fistula	Renal and urinary disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Endometriosis	Reproductive system and breast disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Female Genital Tract Fistula	Reproductive system and breast disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Uterine Haemorrhage	Reproductive system and breast disorders	MedDRA Version 15.0	Systematic Assessment	EG0001 affected98 at risk EG0010 affected138 at risk EG0020 affected195 at risk
Alveolitis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0021 affected195 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0012 affected138 at risk EG0021 affected195 at risk
Mediastinal Mass	Respiratory, thoracic and mediastinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Pleural Fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0021 affected195 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0001 affected98 at risk EG0011 affected138 at risk EG0020 affected195 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0001 affected98 at risk EG0012 affected138 at risk EG0021 affected195 at risk
Pulmonary Hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0020 affected195 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0020 affected195 at risk
Drug Detoxification	Surgical and medical procedures	MedDRA Version 15.0	Systematic Assessment	EG0001 affected98 at risk EG0010 affected138 at risk EG0020 affected195 at risk
Aortic Thrombosis	Vascular disorders	MedDRA Version 15.0	Systematic Assessment	EG0001 affected98 at risk EG0010 affected138 at risk EG0020 affected195 at risk
Deep Vein Thrombosis	Vascular disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0013 affected138 at risk EG0020 affected195 at risk
Haematoma	Vascular disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0022 affected195 at risk
Haemorrhage	Vascular disorders	MedDRA Version 15.0	Systematic Assessment	EG0001 affected98 at risk EG0010 affected138 at risk EG0020 affected195 at risk
Hypertension	Vascular disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0022 affected195 at risk
Hypotension	Vascular disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0011 affected138 at risk EG0020 affected195 at risk
Labile Blood Pressure	Vascular disorders	MedDRA Version 15.0	Systematic Assessment	EG0001 affected98 at risk EG0010 affected138 at risk EG0020 affected195 at risk
Orthostatic Hypotension	Vascular disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk
Subclavian Artery Stenosis	Vascular disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG0010 affected138 at risk EG0021 affected195 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Vertigo	Ear and labyrinth disorders	MedDRA Version 15.0	Systematic Assessment	EG0005 affected98 at risk EG0014 affected138 at risk EG0024 affected195 at risk
Dry Eye	Eye disorders	MedDRA Version 15.0	Systematic Assessment	EG0005 affected98 at risk EG0014 affected138 at risk EG0025 affected195 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0004 affected98 at risk EG00122 affected138 at risk EG00228 affected195 at risk
Gastrooesophageal Reflux Disease	Gastrointestinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0001 affected98 at risk EG0016 affected138 at risk EG00210 affected195 at risk
Nausea	Gastrointestinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0009 affected98 at risk EG00118 affected138 at risk EG00221 affected195 at risk
Vomiting	Gastrointestinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0003 affected98 at risk EG00112 affected138 at risk EG0027 affected195 at risk
Fatigue	General disorders	MedDRA Version 15.0	Systematic Assessment	EG0002 affected98 at risk EG00116 affected138 at risk EG00216 affected195 at risk
Injection Site Erythema	General disorders	MedDRA Version 15.0	Systematic Assessment	EG0006 affected98 at risk EG00113 affected138 at risk EG00218 affected195 at risk
Oedema Peripheral	General disorders	MedDRA Version 15.0	Systematic Assessment	EG0003 affected98 at risk EG00110 affected138 at risk EG00211 affected195 at risk
Pyrexia	General disorders	MedDRA Version 15.0	Systematic Assessment	EG0002 affected98 at risk EG0014 affected138 at risk EG00210 affected195 at risk
Seasonal Allergy	Immune system disorders	MedDRA Version 15.0	Systematic Assessment	EG0002 affected98 at risk EG0019 affected138 at risk EG0022 affected195 at risk
Bronchitis	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG00011 affected98 at risk EG00122 affected138 at risk EG00224 affected195 at risk
Ear Infection	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0002 affected98 at risk EG0017 affected138 at risk EG0028 affected195 at risk
Influenza	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0004 affected98 at risk EG0017 affected138 at risk EG00215 affected195 at risk
Nasopharyngitis	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG00010 affected98 at risk EG00126 affected138 at risk EG00237 affected195 at risk
Oral Herpes	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0006 affected98 at risk EG0019 affected138 at risk EG0027 affected195 at risk
Pneumonia	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0002 affected98 at risk EG0017 affected138 at risk EG0026 affected195 at risk
Rhinitis	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0002 affected98 at risk EG0019 affected138 at risk EG0022 affected195 at risk
Sinusitis	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG00019 affected98 at risk EG00123 affected138 at risk EG00235 affected195 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG00025 affected98 at risk EG00143 affected138 at risk EG00249 affected195 at risk
Urinary Tract Infection	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG00013 affected98 at risk EG00112 affected138 at risk EG00222 affected195 at risk
Viral Infection	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0002 affected98 at risk EG0017 affected138 at risk EG0024 affected195 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA Version 15.0	Systematic Assessment	EG0002 affected98 at risk EG0018 affected138 at risk EG00212 affected195 at risk
Excoriation	Injury, poisoning and procedural complications	MedDRA Version 15.0	Systematic Assessment	EG0003 affected98 at risk EG0016 affected138 at risk EG00210 affected195 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA Version 15.0	Systematic Assessment	EG0002 affected98 at risk EG0017 affected138 at risk EG00214 affected195 at risk
Alanine Aminotransferase Increased	Investigations	MedDRA Version 15.0	Systematic Assessment	EG0006 affected98 at risk EG0010 affected138 at risk EG0025 affected195 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG00012 affected98 at risk EG00120 affected138 at risk EG00225 affected195 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0008 affected98 at risk EG00117 affected138 at risk EG00236 affected195 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0004 affected98 at risk EG0016 affected138 at risk EG00210 affected195 at risk
Joint Swelling	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0001 affected98 at risk EG0018 affected138 at risk EG0023 affected195 at risk
Muscle Spasms	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0001 affected98 at risk EG00112 affected138 at risk EG0026 affected195 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0002 affected98 at risk EG0019 affected138 at risk EG00215 affected195 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0003 affected98 at risk EG0015 affected138 at risk EG00213 affected195 at risk
Pain in Extremity	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0004 affected98 at risk EG0019 affected138 at risk EG00216 affected195 at risk
Rheumatoid Arthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG00014 affected98 at risk EG00123 affected138 at risk EG00253 affected195 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0004 affected98 at risk EG00112 affected138 at risk EG00216 affected195 at risk
Dizziness	Nervous system disorders	MedDRA Version 15.0	Systematic Assessment	EG0004 affected98 at risk EG0018 affected138 at risk EG00210 affected195 at risk
Headache	Nervous system disorders	MedDRA Version 15.0	Systematic Assessment	EG00014 affected98 at risk EG00114 affected138 at risk EG00219 affected195 at risk
Hypoaesthesia	Nervous system disorders	MedDRA Version 15.0	Systematic Assessment	EG0002 affected98 at risk EG0018 affected138 at risk EG0025 affected195 at risk
Paraesthesia	Nervous system disorders	MedDRA Version 15.0	Systematic Assessment	EG0004 affected98 at risk EG0018 affected138 at risk EG00211 affected195 at risk
Anxiety	Psychiatric disorders	MedDRA Version 15.0	Systematic Assessment	EG0001 affected98 at risk EG00112 affected138 at risk EG00211 affected195 at risk
Depression	Psychiatric disorders	MedDRA Version 15.0	Systematic Assessment	EG0003 affected98 at risk EG0018 affected138 at risk EG00218 affected195 at risk
Insomnia	Psychiatric disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected98 at risk EG00111 affected138 at risk EG00211 affected195 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA Version 15.0	Systematic Assessment	EG00010 affected98 at risk EG00113 affected138 at risk EG00224 affected195 at risk
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0004 affected98 at risk EG0018 affected138 at risk EG00215 affected195 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0004 affected98 at risk EG0018 affected138 at risk EG00219 affected195 at risk
Hypertension	Vascular disorders	MedDRA Version 15.0	Systematic Assessment	EG00010 affected98 at risk EG00117 affected138 at risk EG00234 affected195 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Birmingham	Alabama		United States

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Title	Description
BG000	Group 1: Placebo	Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); Golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; Golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-24 database lock.
BG001	Group 2: Golimumab 50 mg	Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); Golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-24 database lock.
BG002	Group 3: Golimumab 100 mg	Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50 mg. Duration of the blinded period was until the week-24 database lock.
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Group 1: Golimumab 50 mg SC Injections Only	Participants who were treated with golimumab and received golimumab 50 mg injections only during the study.	34	98	76	98
EG001	Group 2: Golimumab 100 mg SC Injections Only	Participants who were treated with golimumab and received golimumab 100 mg injections only during the study.	46	138	117	138
EG002	Group 3: Golimumab 50 and 100 mg SC Injections	Participants who were treated with golimumab and received at least one injection of both golimumab 50 mg and golimumab 100 mg during the study.	71	195	172	195